Differences Between Medical Device Trials & Drug Trials

Medical Devices and Drugs are both regulated by the Food and Drug Administration (FDA) though each by a separate division. All drugs must go through a long, rigorous process demonstrating safety at each juncture. The FDA's Center for Drug Evaluation and Research (CDER) must approve the drug before a doctor can prescribe it. Devices are categorized into three classes and regulated and subject to approval by the FDA's Center for Devices and Radiological Health (CDRH) division. Solme devices include tongue depressors, pacemakers, lab equipment and radiation-emitting devices such as X-Ray machines and Ultrasound devices.

Medical Device Approval

• Devices are defined by what they are not. They may not achieve their objective through any chemical or metabolic action within the body. Devices may be an instrument, apparatus, implement, machine or related part that is intended in the diagnosis, cure, mitigation, prevention or treatment of disease. REFERENCE 3 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm

  Devices are then grouped into one of three classes according to the intended use of the device and also upon indications for use and risk. Class I devices are simple apparatuses that are not intended to be of significance to sustaining life and therefore require the least regulation -- 95% of them are exempt from any from of regulation. Included in this class are items such as examination gloves and elastic bandages. REFERENCE 2 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm.

  Class II devices include powered wheelchairs and infusion pumps. Manufacturers must provide the FDA's Center for Devices and Radiological health with evidence the device is comparable to a legally marketed device of its class currently on the market.Class III devices usually are necessarily to support life, are implanted, or present potential risks significant to require PreMarket Approval by the CDRH. Manufacturers seeking to market a Class III device must first submit scientific data that demonstrates the device's safety. Examples of Class III devices include pacemakers, HIV testing kits and breast implants. REFERENCE 4 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm

Drug Approval - PreClinical Testing

• A product is classified as a drug it achieves its results through chemical action or by being metabolized by the body. Its approval process is a long, rigorous process that must demonstrate safety and effectiveness at each of the five phases. The FDA may choose to halt a trial at any stage, and only after the FDA's approval can a drug be placed on the market. The process begins with PreClinical Research and Testing. These initial tests are conducted on live animals, in test tubes and cells in the manufacturer's laboratory and demonstrate the safety of a compound before it can be tested in humans. The manufacturer then submits an Investigational New Drug (IND) Application, which contains all data from preclinical studies, detail of the proposed clinical trials designed to document the drugs safety in human and an explanation of the drug's intended use.

Drug Approval - Clinical Trials

• Once safety in animals has been established, a drug may enter into Clinical Trials, which consists of three phases all of which involve testing in humans. Phase I gauges the drug's safety in a small group of healthy volunteers, and if no serious issues emerge testing proceeds to Phase II Clinical Trials: Larger, randomized, well-controlled, double-blind studies that compare the use of the drug in humans against a placebo. Phase III Clinical Trials may include thousands of patients and are both controlled and uncontrolled. This phase continues to assess safety in addition to side effects, dosage and overall benefit-to-risk ratio.

Drug Approval - New Drug Application and Approval

• Upon completion of Phase III trials with no issues, investigators will submit a New Drug Application (NDA) for FDA review that must include all data from all laboratory, animal and human studies. This data must demonstrate the drug's safety, effectiveness, pharmacological, mechanism of action and include all results of all clinical trials. FDA medical officers, epidemiologists, statisticians and pharmacists review the data to determine its accuracy, evaluate the design of the clinical trials and ultimately decide if the new drug confers a significant benefit to warrant approval. This review process can take years, with the entire drug approval process taking decades. Only after FDA approval can a drug be placed on the market and prescribed.